instructions for use

INSTRUCTIONS FOR USE
PLEASE READ INSTRUCTIONS BEFORE USE. This medical device is to be
used only when prescribed by a physician or licensed practitioner and
operated by trained personnel in accordance with the instructions for use.
3
4
21
14
10
1
25
26
18
27
8
17
5
17
2
16
OFF
28
15
12
11
6
9
23
19
7
22
13
Ultrasound Status Indicator
• No illumination: Power to Transducer is OFF
• Constant Illumination: READY TO TREAT, PAUSED, or PAUSED BY ALARM
• Flashing Illumination: System ACTIVE
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Generator Power Cord
Generator
Power Switch (Back of Generator)
Generator Screen
Scroll Button
Select Button
Back Select Button
Applicator
Transducer
Celleration MIST Therapy
Saline Bottle
11. Treatment Head (Transducer
and Applicator Assembly)
12. Leading Edge of Applicator
13. Transducer Tip
14. Transducer Cradle
15. Ultrasound Control Button
16. Saline Flow On/Off Indicator Arrow
17. Saline Flow “Off” Indicator Mark
(Horizontal)
18. Saline Flow “On” Indicator Mark
(Vertical)
ULTRASOUND
CONTROL
ACTIVE / PAUSE
24
20
19. Symbol for “See Accompanying
Documents”
20. Symbol for “Momentary Contact”
21. Saline Bottle Vent Tab
22. Transducer Cable
23. Saline Flow On/Off Indicator
24. Indicator Light in Ultrasound
Control Button
25. Removable Saline Bottle Cap
26. HELP Button
27. CONTRAST Button
28. Applicator Single-Use Indicator Flag
DESCRIPTION/INDICATIONS FOR USE
Description: The MIST Therapy System uses ultrasound technology to atomize saline and deliver it as
a continuous mist to the treatment site. The mist generated has a relatively uniform droplet size that
acts as a conduit for transmitting ultrasonic energy to the treatment site.
Indications for use:The MIST Therapy System produces a low energy ultrasound-generated mist used
to promote wound healing through wound cleansing and maintenance debridement by the removal of
PL-61000 Rev. A, 12/09
yellow slough, fibrin, tissue exudates and bacteria.
©2009 Celleration , Inc.
®
PREPARING THE PATIENT FOR TREATMENT
WITH THE MIST THERAPY® SYSTEM
• Depending on the wound location, position the patient in a
comfortable position for treatment
• Remove soiled dressings and discard all contaminated materials
(gloves, dressings, pads) prior to a MIST Therapy treatment.
• Use appropriate Infection Control Procedures throughout the
treatment session
• Treatment with the MIST Therapy System will require a clean
environment. Clean the transducer (9) with the provided
germicidal wipes prior to and after use.
• Place an absorbent pad (included in separate applicator kit) under
the portion of the patient being treated to collect the saline runoff.
• Do not reuse applicator or save for future patient use.
PREPARING THE MIST THERAPY SYSTEM
3
2
1
8
4
3
9
16
?
HELP
SELECT
13
Remove the Applicator (8) from its package and press
the Applicator (8) onto the Transducer (9) in one continuous motion, insuring the metal tip (13) is in the center of
the Applicator (8). You should feel a click as the
Applicator (8) is properly seated onto the Transducer (9).
NOTE: Do not touch the
Transducer Tip (13) at any time
while the power is on.
4
Plug the Generator Power Cord (1) into an electrical
outlet. Connect to a “Hospital Grade” or “Hospital
Only” receptacle to achieve grounding reliability.
Turn the Generator (2) “on” using the Power Switch
(3) on the back of the Generator (2).
Once “on”, you will hear a short tone as the
Generator (2) performs a system check (approximately 10 seconds). If the screen (4) does not
respond and remains dark, see Trouble-Shooting.
When the Generator Screen (4) reads "Select Wound
Size", you are ready to continue the setup process.
NOTE: When placing the applicator onto the transducer, make sure the Saline Flow
On/Off Indicator Arrow (16) and the “Off” Indicator Mark (17) are aligned, to ensure
that saline does not flow when bottle is inserted in steps 5 and 6.
5
6
10
50ml
6
10
8
8
50ml
9
7
5
Place the Celleration MIST Therapy Saline Bottle
(10) upright into the Applicator (8), using the
Applicator walls as guidance. The "cup" opening
and gradations on the bottle should be facing the
Transducer (9).
Engage the Celleration MIST Therapy Saline Bottle
(10) using one forceful, downward thrust into the
Applicator (8) to puncture the Celleration MIST
Therapy Saline Bottle (10).
Choose the wound size (cm2) by moving the Arrow
Buttons (5) on the Generator (2) unit up or down.
The corresponding treatment time for a given
wound size will appear as well.
The Applicator (8) is designed as a disposable unit
to avoid contamination risk. Do not remove the
Celleration MIST Therapy Saline Bottle (10) once
engaged.
Press Select Button (6) to lock in the correct treatment time. If the incorrect time is entered, use the
Back Select Button (7) to alter the treatment time by
using the Arrow Buttons (5) and then, pressing the
Select Button (6).
TREATMENT TIMES GREATER THAN SALINE BOTTLE CAN PROVIDE
When treating wounds with areas of greater
than 30 cm2 on the same patient, it will be
necessary to refill the saline bottle approximately every five minutes or as required to
fulfill a treatment.
To refill, remove the cap (25) (the cap is
scored for easy removal at the neck of the
bottle) from the initial saline bottle that is
already seated in the applicator assembly. If
you know that you will be refilling for longer
treatment times it is recommended that the
cap be removed before starting the initial
treatment. Refill the saline bottle from a second saline bottle (with just the tab removed).
Multiple wounds on the same patient can
be treated by refilling the saline bottle (10).
Follow your local infection control procedures. Do not reuse applicator between
patients or retain for future patient use.
When treatment of a patient is complete,
remove the applicator and discard.
TREATING THE PATIENT WITH THE MIST THERAPY® SYSTEM
NOTE: Treatment with the MIST
Therapy System should occur shortly
after preparation.
Preparation of the system in advance of
treatment may lead to saline loss if the
applicator valve has been inadvertently
opened.
Follow infection control procedure per
facility policies.
1
21
10
Hold the Treatment Head (11) (transducer and applicator assembly) firmly in one hand and gently twist
off the Vent Tab (21) from the Celleration MIST
Therapy Saline Bottle (10) by grasping the Vent Tab
(21) and turning. Discard the Vent Tab. This will create a vent in the Celleration MIST Therapy Saline
Bottle (10) and allow saline to flow upon completing
step 2. Be sure not to turn the bottle and portion of
the Applicator (8) holding the bottle at this time.
PL-61000 Rev. A, 12/09
©2009 Celleration®, Inc.
2
3
15
10
50ml
11
18
11
24
16
To initiate saline flow, turn Celleration MIST Therapy® Saline Bottle (10) and
Applicator (8) in a counter clockwise motion until the “On” Indicator (18) on the
applicator is aligned with the On/Off Arrow on the applicator (16). Allow the saline
to flow through the applicator for 3-5 seconds. Do not let saline flow any longer
than that or the saline will build up within the Applicator (8) and create an inconsistent therapeutic mist.
4
The Treatment Head (11) should be held so that it is perpendicular to the
wound with the Leading Edge of Applicator (12) approximately 0.5 to 1.5 cm
(0.2 - 0.6 inches) from the wound. You are now ready to begin treatment. Indicator
(24) is solid green.
Depress and release the Control Button (15) at the top of the Treatment Head (11).
Indicator (24) is flashing green. You may pause treatment by pushing the Control
Button (15) (now solid green) again and rotating the saline bottle to the off
position. Never activate the transducer (11) without applicator (8) in place.
5
l
50m
11
4
0.5 - 1.5 cm
23
?
HELP
(Spray Pattern)
SELECT
The MIST Therapy System will begin to deliver a continuous mist. Move the Treatment Head (11) vertically
across the wound using multiple passes. Follow this by moving the Treatment Head (11) horizontally across the
wound using multiple passes. The Treatment Head (11) should be moved in front of the wound using slow, even
strokes and should not be waved in a swinging fashion. The distance between the Treatment Head and wound
can be varied as well between the 0.5 to 1.5 cm (0.2 - 0.6 inches) during treatment. Audible and visual bubbling
may occur. This is normal when moving back and forth through the recommended treatment range.
Continue treatment (ACTIVE) until you hear three
long tones and the Generator Screen (4) returns to
the Select Treatment Time mode.
Once the treatment is completed, the transducer (II)
will automatically deactivate, insuring accurate
treatment time for the wound size selected.
NOTE: IT IS IMPORTANT TO MAINTAIN A 0.5 TO 1.5 CM (0.2 - 0.6 INCHES) DISTANCE FROM THE LEADING
EDGE OF THE APPLICATOR (12) TO THE WOUND AT ALL TIMES TO MAXIMIZE THERAPEUTIC EFFECT.
6
7
8
11
8
17
10
Locking mechanism is in
the “locked” position
and can not be reused.
16
28
Rotate the Celleration MIST Therapy Saline Bottle (10)
in a clockwise direction to stop the flow of saline. There
may be saline remaining in the bottle. This is normal
depending upon the size of the wound selected.
With the system power off (3), remove the Applicator
(8) from the Treatment Head (11), place the
Transducer (9) into the Transducer Cradle (14) and
discard the Applicator (8) appropriately.
Do not remove the applicator until the treatment has
been completed. The applicator has an integrated
mechanical locking mechanism that prevents reuse
or re-engagement to the transducer once removed.
PREPARATION AND CLEANING OF MIST THERAPY® SYSTEM
Clean the MIST Therapy System prior to and after each treatment session with the Power Button (3) in the “off” position.
1
2
14
2
13
CAUTION: CELLERATION MIST THERAPY
SALINE BOTTLE (10) AND APPLICATOR (8)
ARE DESIGNED AS SINGLE PATIENT-USE DISPOSABLE UNITS TO AVOID CONTAMINATION
AND SHOULD NOT BE RE-USED BETWEEN
PATIENTS OR RETAINED FOR FUTURE USE.
9
22
Prior to treatment use the first germicidal wipe to
clean the system. First, wipe the generator (2) and
cradle (14). Then wipe the transducer cable (22),
transducer handle (9), and then proceed to wipe
the transducer tip (13). Do not sterilize the treatment head (11) with steam, ETO, or cold sterilants.
After completion of the MIST Therapy treatment,
discard the single-use disposable applicator and
use the second germicidal wipe provided to repeat
the cleaning process as described in step one.
PL-61000 Rev. A, 12/09
©2009 Celleration®, Inc.
CELLERATION®, INC.
SUMMARY OF CLINICAL RESULTS FOR LABELING
CLINICAL TRIAL EFFECTIVENESS RESULTS
This primary objective of the prospective, randomized, controlled clinical trial was to compare the
incidence of complete wound closure achieved among chronic diabetic foot ulcers receiving MIST®
Therapy in relation to SHAM control by or on week 12.
Complete wound closure was defined as full epithelialization without drainage. After a wound was initially considered healed, all patients were scheduled for a return visit one week later to confirm wound
closure.The confirmatory visit date was used as the official closure date for the purpose of this analysis.
The incidence of index ulcer closure within 12-weeks according to treatment group among 63 evaluable patients is presented in the following table. Thirty-five point five percent (11/31 patients) of the
diabetic foot ulcers treated using the MIST treatment were found to close within 12 weeks of treatment, while only 12.5% (4/32 patients) of the foot ulcers in the SHAM treatment group were found to
close within the same treatment period (p = 0.032).
Incidence of Index Ulcer Closure Status by Treatment Group
MIST (n=31 pts)
Closure
Closed
Not Closed
Total
Control (n=32 pts)
Total (n=63 pts)
No.
%
No.
%
No.
%
11
20
31
35.5
64.5
4
28
32
12.5
87.5
15
48
63
23.8
76.2
p-value = 0.0322; Chi-Square Test.
The following figure displays the survival curves using Kaplan-Meier product limit estimates of the
time-to-closure for both treatment groups. The difference in time to closure observed between the
two treatment groups was found to be statistically significant (Log-rank p=0.0090; Wilcoxon p=0.0116)
with at marked separation between the two survival curves occurring at the fourth week of treatment. This significant difference remained after controlling for the possible confounding effects of
age, gender, baseline area of the index ulcer, use of off-loading device, percent of visits where
debridement was performed, intensity of debridement, chronicity of the index ulcer at baseline and
investigational center (p=0.0061).
Survival Analysis of
Closure Status by
Treatment Group
PL-61000 Rev. A, 12/09
©2009 Celleration®, Inc.
ADVERSE EVENTS
The MIST Therapy® System has been evaluated in four clinical evaluations involving 263 patients
with a variety of wounds including: recalcitrant pressure ulcers, chronic lower extremity leg and foot
ulcers and diabetic foot ulcers. Among these, a prospective, randomized, controlled clinical trial was
conducted to evaluate the safety and effectiveness of MIST Therapy System in relation to SHAM control when added to standard-of-care when used in the treatment of chronic diabetic neuropathic foot
wounds.
A total of 133 patients presenting with diabetic neuropathic foot ulcers were enrolled into the study.
This primary safety objective of the study was to compare the incidence of adverse events among
patients receiving MIST in relation to SHAM control through the 12-week treatment period.
A total of 143 adverse events were reported among the 133 patients, (with at least one adverse event
being reported for 45 of the 70 (64.3%) MIST patients and 40 of the 63 (63.5%) SHAM control patients
(p = 1.0, Fisher’s Exact Test)). No significant differences were found in the incidence of any of the
adverse events between treatment groups (p>0.05).
In addition to the incidence of adverse events, this clinical trial also evaluated the severity, device
relatedness and seriousness of the events. No statistically significant or clinically important differences were identified between the MIST treatment group and the SHAM control group in the incidence, severity, device-relatedness, or seriousness of adverse events.
Incidence of Adverse Events by Treatment Group
MIST (n=70 pts)
Adverse Event
Additional ulcer(s)
Cellulitis
Edema
Erythema
Hyperglycemia
Osteomyelitis
Pain
Tingling
Ulcer Drainage
Ulcer Enlargement
Ulcer Infection
Other
Total Number of AE’s
Control (n=63 pts)
Total (n=133 pts)
No.
%
No.
%
No.
%
14
9
3
3
1
1
5
1
1
2
13
27
80
20
13
4
4
1
4
7
1
1
3
19
39
9
8
3
4
0
3
6
0
1
2
9
18
63
14
13
5
6
0
5
10
0
2
3
14
29
23
17
6
7
1
4
11
1
2
4
22
45
143
17
13
5
5
1
3
8
1
2
3
17
34
NOTE: Counts and percentages represent incidence of Adverse Event within each patient. It does not
account for multiple occurrences of the same event within patients.
p > 0.05; Fisher’s Exact Test
PL-61000 Rev. A, 12/09
©2009 Celleration®, Inc.
CAUTIONS/ATTENTION
PRECAUTIONS/PRÉCAUTIONS
Caution: Federal Law restricts this device to the sale by, or on
order of, a physician or other practitioner licenced in the state in
which said person practices.
Treatment effectiveness will be diminished if any of the
following occur:
Attention : La législation fédérale (É.-U.) limite la vente de ce dispositif à un médecin ou à la prescription d’un médecin ou d’un
autre praticien diplômé dans l’état où il exerce.
Caution: Risk of electric shock - Do not remove cover or loosen
cable connections. Refer servicing to qualified service personnel.
Attention : Risque d’électrocution – Ne pas retirer le capot ni
desserrer les branchements de câbles. Confier l’entretien à un
personnel technique qualifié.
Caution: Do not use if transducer or cables show evidence of
deterioration or damage. Discard disposable applicator components appropriately.
Attention : Ne pas utiliser si le capteur ou les câbles présentent
des signes de détérioration ou d’endommagement. Mettre au
rebut les composants jetables de l’applicateur de manière
appropriée.
Caution: Risk of burns - Do not touch the metal tip of the
transducer during operation. - Never depress butto
without applicator in place.
L’efficacité du traitement sera compromise dans l’une des
situations suivantes :
• The Applicator (8) is not fully engaged, aligned and securely
attached to the Transducer (9) and Saline (10) has not been
turned on with mist being produced within 5 seconds of
Ultrasound Control Button (15) activation.
• L’applicateur (8) n’est pas enclenché à fond, aligné ni solidement attaché au capteur (9) et l’arrivée de sérum physiologique (10) n’a pas été ouverte avec production d’un brouillard
dans les 5 secondes de l’activation du bouton de commande
des ultrasons (15).
• The distance between the Leading Edge of the Applicator (8)
and the wound is greater than 1.5 cm (0.6 inches)
• La distance entre le bord avant de l’applicateur (8) et la plaie
est supérieure à 1,5 cm.
•TheTreatment Head (11) is not held perpendicular to the wound.
• La tête de traitement (11) n’est pas perpendiculaire à la plaie.
• The Celleration MIST Therapy Saline (10) has been
contaminated.
Attention : Risque de brûlures – Ne pas toucher l’extrémité
métallique du capteur en cours d’utilisation. – Ne jamais
appuyer sur le bouton sans que l’applicateur soit en place.
• Le sérum physiologique Celleration MIST Therapy (10) a
été contaminé.
Caution: Always have the applicator properly seated and saline
turned on when activating the Ultrasound Control Button (15).
Turn power off and see Trouble-Shooting section if fluid is leaking
around applicator.
Attention : S’assurer toujours que l’applicateur est correctement enfoncé et ouvrir l’arrivée de sérum physiologique au
moment d’activer le bouton de commande des ultrasons (15).
Mettre hors tension et consulter la section « Dépannage » en cas de
fuite de liquide au niveau de l’applicateur.
Caution: Use only the Celleration MISTTherapy® saline with the
MIST Therapy System.
Attention : Utiliser uniquement le sérum physiologique
Celleration MIST Therapy avec le système MIST Therapy.
Do not touch the inside surfaces of the applicator (8), and specifically the barb, as injury may occur.
Ne pas toucher les surfaces intérieures de l’applicateur (8), surtout
sa partie crantée sous peine de blessures.
Caution: Celleration MIST Therapy Saline Bottle (10) and
Applicator (8) are designed as single-use disposable units to
avoid contamination and should not be re-used.
The MIST Therapy System requires an order by a physician or
licensed practitioner. Only personnel trained on its use should
perform treatment with the MIST Therapy System and should
be used only as directed.
Attention : La bouteille de sérum physiologique (10) et l’applicateur (8) du système Celleration MIST Therapy sont conçus
comme des composants jetables à usage unique pour éviter
toute contamination. Ne pas les réutiliser.
Le système MIST Therapy exige la prescription par un médecin
ou un praticien diplômé. Seul un personnel formé à son utilisation doit effectuer un traitement avec le système MIST
Therapy en l’utilisant conformément à son mode d’emploi.
POTENTIAL COMPLICATIONS/ÉVENTUELLES COMPLICATIONS
• Tingling
• Redness
• Fourmillement
• Rougeur
CONTRAINDICATIONS/CONTRE-INDICATIONS
Contraindications: Do not use near electronic implants/
prosthesis (e.g. Near or over the heart or over the thoracic area
if the patient is using a cardiac pacemaker); on the lower back
during pregnancy or over the pregnant uterus; over areas of
malignancies.
Contre-indications : Ne pas utiliser à proximité d’un implant ou
d’une prothèse électronique ou à proximité ou au-dessus du
coeur ou de la zone thoracique si le patient est porteur d’un
stimulateur cardiaque ; sur le bas du dos durant une grossesse
ou au-dessus de l’utérus de la femme enceinte ; au-dessus de
zones de malignités.
PL-61000 Rev. A, 12/09
©2009 Celleration®, Inc.
TROUBLESHOOTING
SYSTEM WILL NOT TURN ON OR PROGRESS
THROUGH THE SELF TEST TO “SELECT WOUND
SIZE” MODE
•
•
•
•
Check to ensure Power Cord (1) is properly seated in the Generator (2) outlet
Insure power is coming from outlet
Cycle the Power Button (3) on the Generator (2)
Check fuses on back of Generator (2) (see technical description or fuse label
for replacement)
SYSTEM WILL NOT ACCEPT A TIME ALTERATION
• Shut down unit and re-start the Generator (2)
MIST IS NOT COMING OUT OF THE APPLICATOR
• Insure Power Button (3) is on and Indicator (24) on Control Button (15) is active
• Insure Celleration MIST Therapy® Saline Bottle (10) is engaged into Applicator (8)
and Vent Tab (21) is removed.
• Insure that the button is being depressed firmly on the Treatment Head (11)
and released.
• Insure Transducer Tip (13) is aligned in center of Applicator (8)
(a consistent air gap between the Applicator (8) and the Transducer Tip (13)
when viewing the Treatment Head (11) from the front)
• If an obstruction is apparent between the Celleration MIST Therapy Saline
Bottle (10) and Applicator (8) or Transducer Tip (13), change Applicator (8)
• If steps above fail, shut down unit and re-start the Generator (2)
SYSTEM SHUTS DOWN
• Insure treatment time has not elapsed
• System shows “Paused By Alarm…”
• Alarm condition reads: “FREQSLIP”;Turn Power Button (3) off and restart
Generator (2); Call service if alarm condition continues
• Alarm condition: “OVERHEAT”;Turn Power Button (3) off for at least five minutes
and restart Generator (2); Call service if alarm condition exists after 10 minutes
of non-use.
• Alarm Condition: “HI OUT”;Turn off Power Button (3) and restart after
five minutes. Call Service if alarm condition continues.
• Alarm Condition: “COMM FAIL”;Turn off Power Button (3) and restart
Generator (2), call Service if alarm condition continues.
• Alarm condition: “LOW OUT”;Turn Power Button (3) off and restart
Generator (2); call for service if alarm condition continues.
• Alarm condition: “HV CNTL”;Turn Power Button (3) off and restart Generator
(2); call for service if alarm condition continues.
FLUID LEAKAGE AROUND APPLICATOR
• Replace Applicator (8) with close attention to insert Saline Bottle (10) with one
forceful downward thrust and without subsequent lifting of the saline bottle (10).
ALTERNATE FUNCTION KEYS
• HELP (26): Displays a help message in the SelectTreatmentTime screen.
This message is displayed for 10 seconds or can be cleared before by
pressing the 'HELP' button again.
• CONTRAST (27): While holding down contrast button, press Up or Down Arrow
Buttons (5) to adjust screen contrast.
UNABLE TO FULLY ENGAGE APPLICATOR
ONTO TRANSDUCER
• Check for applicator single-use flag(28). If flag is up it indicates applicator has been
used. Discard and replace with unused applicator.
TECHNICAL SERVICE
For technical questions about the operation of the MIST Therapy System call 1-866-307-MIST (6478).
Refer servicing to qualified service personnel.
MIST Therapy System Technical Description
Class I, Type B Applied Part
IPX1
Rated as DRIP–PROOF
Equipment
See Accompanying Documents
• System Classification: Class I, Type B Applied Part
Single-Use Device
0086
• Resistance to ingress of fluid: IPX1, Drip-proof
+35391443609
• For US or Canadian Operation: (115V, 60Hz, 50W)
- Use only Celleration part number CP-80009 detachable power cord listed for ‘HOSPITAL USE’, 125V, 10A
- Connect to a “Hospital Grade” or “Hospital Only” receptacle to achieve grounding reliability.
- Replacement fuse: T0.630A 250V (5x20mm)
• Transducer Output: Max. intensity at 10mm: 1.7 W/cm2; Leading edge of applicator (12) is 10mm from the transducer
tip (13). Unintentional Output: <100mW/cm2 to user.
• Storage: Store in a dry, ambient temperature environment.
• Operating Temperature: 50 to 90 degrees Fahrenheit at a relative humidity of 30 to 75% (non-condensing)
• Covered by or for use under one or more of the following U.S. patents: 6,569,099; 6,964,647; and 6,960,173; and other
U.S. and foreign patents pending.
PL-61000 Rev. A, 12/09
©2009 Celleration®, Inc.
SUGGESTED REFERENCES
1. Schoenbach SF and Song IC. Ultrasonic debridement: a new approach in the treatment of burn wounds. Plastic and
Reconstructive Surgery, 1980; 66(1): 34-37.
2. Nichter LS, et al. Efficacy of debridement and primary closure of contaminated wounds: a comparison of
methods. Annals of Plastic Surgery, 1989; 23(3): 224-230.
3. MacDonald WS and Nichter LS. Debridement of bacterial and particulate-contaminated wounds. Annals of Plastic
Surgery, 1994; 33(2): 142-147.
4. Nichter LS and Williams J. Ultrasonic wound debridement. The Journal of Hand Surgery, 1988; 13A(1): 142-146.
5. Collier M. Sterile saline versus tap water: which is most effective? Journal of Wound Care, 2002; 11(6): 218.
6. Phillips D and Davey C. Wound cleaning versus wound disinfection: a challenging dilemma. Perspectives, 1997;
21(4): 15-16.
7. Goode PS and Thomas DR. Pressure ulcers: local wound care. Clinical Geriatric Medicine, 1997; 13(3): 543-552.
8. Angeras MH, et al. Comparison between a sterile saline and tap water for the cleaning of acute traumatic soft
tissue wounds. European Journal of Surgery, 1992; 158(6-7): 347-350.
9. Gouin S and Patel H. Office management of minor wounds. Canadian Family Physician, 2001; 47: 769-774.
10. Chisholm CD. Wound evaluation and cleansing. Emergency Medical Clinics of North America, 1992; 10(4): 665-672.
Celleration® Inc.
10250 Valley View Road Suite 137
Eden Prairie, Minnesota 55344
U.S.A. Phone: 1-866-307-MIST (6478)
www.celleration.com
PL-61000 Rev. A, 12/09
©2009 Celleration®, Inc.